Senior Quality Engineer (Post Market)

Actalent • Miami, FL • 3w ago

Staff Quality Engineer (Post Market) Medical Devices

Job Description

The Staff Quality Engineer is mainly responsible for providing quality engineering support with a particular focus on post market activities. This position will also involve working with manufacturing, R&D, Marketing, Sales, and other Quality functions to address post market feedback. Additionally, the role includes collaborating with the QMS team to ensure post market processes are defined, implemented, and maintained.

Responsibilities

Develop, modify, apply, and maintain quality standards.

Ensure that corrective measures meet acceptable standards and that documentation is compliant with requirements.

Have the authority to stop any potential non-conforming processing, shipments, and manufacturing and escalate to Quality Management and/or Executive Management.

Apply and understand statistical methodologies for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.

Lead and/or participate in corrective/preventive action teams in resolving production, customer, and supplier issues such as nonconformance's, CAPA activities, audit findings, and complaint investigations.

Identify, analyze, and manage risk throughout the product lifecycle using FMEA and other risk management tools.

Report on post market metrics.

Lead complaint board meetings.

Prepare, review, and oversee Health Hazard Evaluations (HHE).

Execute, monitor, and oversee the recall process.

Prepare and submit Medical Device Reports (MDR) and other regulatory complaint reports as required.

Handle complaints from intake to closure, including determination, investigation, and reporting.

Essential Skills

Experience in MDR for the US, including preparation and submission of reports.

Ability to document in an electronic system

Capability to make MDR decisions

Proficiency in complaint handling from intake to closure with an emphasis on timely resolution.

Post market experience.

Bachelor's Degree in Engineering or equivalent experience (5+ years preferred).

Work Environment

On-Site

Pay and Benefits

The pay range for this position is $65.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on Apr 17, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

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